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51 results
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Independent data monitoring committees: preparing a path for the future.
Hess CN, Roe MT, Gibson CM, Temple RJ, Pencina MJ, Zarin DA, Anstrom KJ, Alexander JH, Sherman RE, Fiedorek FT, Mahaffey KW, Lee KL, Chow SC, Armstrong PW, Califf RM. Hess CN, et al. Among authors: sherman re. Am Heart J. 2014 Aug;168(2):135-41.e1. doi: 10.1016/j.ahj.2014.05.003. Epub 2014 May 15. Am Heart J. 2014. PMID: 25066551 Free PMC article.
The FDA Sentinel Initiative - An Evolving National Resource.
Platt R, Brown JS, Robb M, McClellan M, Ball R, Nguyen MD, Sherman RE. Platt R, et al. Among authors: sherman re. N Engl J Med. 2018 Nov 29;379(22):2091-2093. doi: 10.1056/NEJMp1809643. N Engl J Med. 2018. PMID: 30485777 No abstract available.
Flexibility in the FDA approach to orphan drug development.
Hunter NL, Rao GR, Sherman RE. Hunter NL, et al. Among authors: sherman re. Nat Rev Drug Discov. 2017 Nov;16(11):737-738. doi: 10.1038/nrd.2017.151. Epub 2017 Sep 1. Nat Rev Drug Discov. 2017. PMID: 28860647 No abstract available.
Combination products: modernizing the regulatory paradigm.
Hunter NL, Sherman RE. Hunter NL, et al. Among authors: sherman re. Nat Rev Drug Discov. 2017 Aug;16(8):513-514. doi: 10.1038/nrd.2017.66. Epub 2017 May 12. Nat Rev Drug Discov. 2017. PMID: 28496147
Real-World Evidence - What Is It and What Can It Tell Us?
Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM. Sherman RE, et al. N Engl J Med. 2016 Dec 8;375(23):2293-2297. doi: 10.1056/NEJMsb1609216. N Engl J Med. 2016. PMID: 27959688 No abstract available.
51 results